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Year : 2016 | Volume : 4 | Issue : 4 | Page : 211 - 215  


Original Articles
Effect of Drotaverine administration on cervical dilatation in uncomplicated deliveries

Shah Sangeeta1, Bandhavi Lagisetti2

1 Associate Professor GMC Nizamabad,

2 Senior Resident, GMC Nizamabad

Corresponding Author:

Dr. Shah Sangeeta

Email: drsshah19@yahoo.com

ABSTRACT:

Background: Prolonged labour can lead to increased maternal and neonatal mortality and morbidities. Active management of labour versus physiological, expectant management has shown to decrease the occurrence of prolonged labour. Administering antispasmodics during labour could lead to faster and more effective dilatation of the cervix.

Objective: To know the effect of Drotaverine on dilatation of cervix in uncomplicated deliveries compared to the data obtained in patients without smooth muscle relaxants

METHODS: This study was conducted on 200 cases of uncomplicated pregnancies. 100 cases in study group and 100 cases in control group who fulfilled the relevant criteria were admitted in department of OBG in Government Medical College-Nizamabad-Telangana. Cases in study group were given 40mg of Drotaverine IM, when cervix was 3cms dilated and then labour was monitored using partogram. Second dose of Drotaverine was given 2 hrs after the first dose depending on progress of labour. RESULTS: The average duration of dilatation stage was 4 hours and 10 minutes (250mins) in primigravida of study group while it was 6 hours and 30 minutes (390min) in control group. The average duration of dilatation stage was 3 hours (180min) in second gravida in study group, while it was 4hrs 30 min (270min) in control group

CONCLUSION: Intramuscular administration of Drotaverine injection in dilatation phase of uncomplicated pregnancies was found to reduce the duration of cervical dilatation, total duration of labour, and incidence of cervical tears with no change in stage 2 and 3 of labour.

Key words: Prolonged labour, cervical dilatation, Drotaverine.

INTRODUCTION:

Labour is arbitrarily defined as being prolonged when its duration exceeds 18 hours in primigravida as prolonged if it exceeds and 12 hours in multigraavidas. Cervical dilatation is one of the important factors which determine the duration of labour, as failure of the cervix to dilate can cause prolonged labour. The problems and hazards of prolonged labour, both for the mother and fetus, have been recognized for many years. Due to prolonged labour mother is exposed to a higher risk of infection, ketosis and obstructed labour, while the fetus faces the dangers of infection, asphyxia. In prolonged labour cervical dilatation plays a significant role.

The commonly used mechanical methods for cervical dilatation are Stripping of membranes, amniotomy and transcervical catheterization. The pharmacological methods include use of drugs such as Oxytocin, Prostaglandin, Buscopan, Valethamate bromide and Drotaverine hydrochloride. The present study uses Drotaverine intramuscularly to facilitate cervical dilatation. Drotaverine is 3, 4, 6, 7, tetra ethoxy 1 benzyl 1,2,3,4, tetra hydroisoquinolone hydrochloride. [1]

Molecular mechanism of spasmolytic properties are calcium antagonism, calmodulin antagonism, phosphodiesterase inhibition, phosphodiesterase IV isoenzyme selectivity and sodium channel Antagonism

BIOCHEMICAL BASIS:

Inhibition of phosphodiesterase enzyme leads to increase in cAMP level, which in turn decreases the availability of free intra-cytoplasmic calcium ions leading to smooth muscle relaxation [2]

HUMAN PHARMOCOKINETICS AND METABOLISM

After a single oral dose of 80 mg Drotaverine hydrochloride the peak plasma concentration of the parent compound appears 2 hours after the administration. 65% of the drug reaches systemic circulation unchanged. In vitro Drotaverine is highly bound to human plasma protein, 95-98% especially to albumin and, globulin and a (HDL) lipoprotein [1, 3] After IV administration the terminal half-life of the parent compound is about 2-4 hours in one trial and 9 hours in other. 51-58% and 31-36% of the dose administered intravenously are eliminated in urine and feces respectively within 168 hours. [4]Drotaverine is almost completely metabolized by desethylation to monophenolic. Drotaverine is found to be of primary benefit to the primipara by shortening the first stage of labour [6]

The I.M. and/or I.V. administration of Drotaverine in the final phase of dilatation of uterine cervix resulted in a facilitated dilatation and shortened time. Drotaverine significantly reduces the incidence of cervical tears which may present an immediate risk due to bleeding and act as forerunners of infection.

Each 2 ml ampoule of Drotaverine injection contains 40 mg Drotaverine hydrochloride. Usually two doses of IM injections are given two hours apart.

SAFETY AND SIDE EFFECTS: Drotaverine has no serious adverse effects and is well tolerated by all age groups. It has neither embryo toxic nor teratogenic effects. The objectives of the present study are: to study the effect of intra muscular administration of Drotaverine during active phase of dilatation in uncomplicated deliveries compared to the data obtained in patients without smooth muscle relaxant, to study the effect on the duration of the dilatation stage, total duration of labour and incidence of cervical tears.

MATERIAL & METHODS:

This is an experimental study design and the study was conducted in Government Medical College –Nizamabad during the period August-2015 to March-2016 after taking approval from the Institutional Ethics Committee. 100 women in the study group and 100 in the control group, all in the age group 18-30years were included after taking informed consent. The participants were randomly selected from those who were admitted in the labour room and who fulfilled the following inclusion and exclusion criteria.

A careful history was taken from all the patients about age, parity, period of gestation, LMP, EDD, duration of labour pains and history of any leaking and bleeding P/V, complete obstetric history was taken. Thorough physical examination was done to know the general condition of the patient that is, any pallor and pedal edema was noted, pulse rate and BP recording was done. Heart and lungs were checked. Obstetric examination was done to know the fundal height, lie, presentation of the fetus, adequacy of liquor, estimated fetal weight; Careful auscultation for fetal heart was done. Uterine contractions-number of contractions and duration of each contraction in 10 minutes were noted. Per vaginal examination was done to know state of cervix; effacement and dilatation, station of the presenting part, status of the membranes. All preliminary investigations such as blood grouping and typing, hemoglobin estimation, complete urine examination, random blood sugar and ultrasonography were done.

The primary end point of the study is delivery of the baby.

Following parameters were recorded in every patient during labour

1: Progress of labour using a partogram:

  1. Frequency and duration of uterine contractions were evaluated clinically by abdominal palpation every 30minutes.
  2. Cervical effacement and dilatation were recorded every four hours by per vaginal examination. Per vaginum examination was done earlier if rupture of membranes occurred, patient started bearing down, significant changes in FHS were found, meconium stained liquor was observed.
  3. c) Station and position of presenting part were noted at the same time.

2: Maternal wellbeing was assessed with pulse rate, Blood pressure and any other side effects like nausea, vomiting, palpitations, tachycardia, dryness of mouth, flushing, headache, hypotension were noted and treated accordingly.

3: Fetal wellbeing was assessed by fetal heart rate and color of amniotic fluid and Apgar score at 1 and 5 minutes.

TREATMENT PLAN STUDY GROUP: Patients under study group were given 40mg Drotaverine intramuscularly when the cervix was effaced and 3 cm dilated. Labour was monitored drawing a partogram noting the duration of cervical dilatation. Depending on the progress of labour second dose of Drotaverine is given after 2 hrs of initial injection. Whenever relative CPD, fetal distress was encountered or instrumental delivery was done the case was withdrawn from the study. CONTROL GROUP: The same protocol was followed in the control group without administration of Drotaverine

As soon as the head was born thorough suction of ororpharynx and nasopharynx was done with mucus sucker. One minute APGAR scoring was done. Baby’s cord was clamped, and baby was taken to the new born room. Weight of the baby and gestational age noted. One minute and five minute APGAR scoring was done. Duration of first stage, second stage, and third stage were recorded in both groups. Any complications, adverse events, blood loss were recorded

INCLUSION CRITERIA

EXCLUSION CRITERIA

Healthy parturients

No obstetric complications

Intact membranes

Cervical dilatation at least 3cms

Partially effaced cervix

Regular, established uterine contractions.

Cephalic presentations.

Multiple pregnancy

Fetal mal-presentations and malformations

Induced labour

Cervical surgery in the past history

Women having carried four or more pregnancies

Systolic pressure below 100mm of Hg or above 150 mm of Hg

Diastolic pressure above 90mm of hg

Anti hypertensive therapy

Known hypersensitivity to Drotaverine.

Cephalopelvic disproportion

Medical disorders in pregnancy

Preeclampsia and eclampsia.

RESULTS:

A total of 100 cases in the study group and 100 cases in control group were enrolled in the study. The results were subjected to chi-square test to test the significance.

Table 1: distribution of cases according to gravidity

GRAVIDA

NO.OFCASES

Total (%)

STUDY GROUP

CONTROL GROUP

PRIMI-

GRAVIDA

42

46

44

SECOND

GRAVIDA

34

34

34

THIRD GRAVIDA

24

20

22

TOTAL

100

100

100

Total of 200 cases in which 100 are in study and 100 in control group. Most of them (44%) are primigravida.

Table 2: Distribution of cases according to age

Age groups(in years)

NO OF CASES

Total

STUDY

CONTROL

18-20

21

14

17.50

21-25

49

62

55.50

26-30

30

24

27.00

TOTAL

100

100

100

The difference in the age groups in two groups is not statistically significant P value of 0.422. Highest number of patients was between 21-25 years 49 in study group and 62 in control group respectively.

Table 3: duration of active phase of dilatation

Time(In Hrs)

Primi

Gravida

Second Gravida

Third Gravida

Study

Control

Study

Control

Study

Control

1-3hrs

09(21%)

03(06%)

10(30%)

04(12%)

10(42%)

06(30%)

3-6hrs

29(69%)

11(24%)

22(64%)

16(47%)

14(58%)

12(60%)

6-9hrs

02(05%)

28(61%)

02(06%)

12(35%)

-

02(10%)

9-12hrs

02(05%)

04(09%)

-

02(06%)

-

-

In the study group 69% of primigravida became fully dilated from active phase of dilatation in 3-6hour, while in control group 61% in 6-9 hours. Second gravida in study group 64% became fully dilated from active phase of dilatation in 3-6 hours, while in control group 47% in 3-6 hours, 35% in 6-9hrs. There was no statistical difference between study group and control group in third gravid as p>0.05. The average duration of dilatation stage was 4hours 10 minutes(250 mints) in primigravida of study group, while it was 6hours 30 minutes(390mints) in control group P<0.05 which is statistically significant.Duration of second stage of labour in most of the patients was from 0-1/2 hour in primis and multies. Duration of second showed no difference between study group and control group both in primis and multies as calculated X2 value was less than tabulated value(p>0.05)

Table 4: duration of second stage of labour

Time(In Hrs)

Primigravida

Second gravida

Third gravida

Study

Control

Study

Control

Study

Control

0-half an hour

26(62%)

27(59%)

24(71%)

24(80%)

20(84%)

16(80%)

half an hour-1

13(31%)

15(33%)

09(26%)

10(20%)

04(16%)

04(20%)

1-2

03(07%)

04(08%)

01(03%)

0

0

0

Table 5: Duration of third stage of labour

Time(In Min)

Primigravida

Second Gravida

Third Gravida

Study

Control

Study

Control

Study

Control

0-10

40(95%)

43(93%)

33(97%)

32(94%)

23(96%)

19(95%)

10-20

02(05%)

03(07%)

01(03%)

02(06%)

01(04%)

01(05%)

Duration of third stage of labour was 0-10 minutes in maximum number of patients. Duration of third stage did not alter between study group and control group (p>0.05) not significant.

Table 6: total duration of labour

Time(in hrs)

Primigravida

Second gravida

Third gravida

Study

Control

Study

Control

Study

Control

1-3hrs

06(14%)

01(02%)

10(30%)

02(06%)

06(42%)

05(25%)

3-6hrs

28(67%)

13(28%)

22(65%)

12(35%)

18(58%)

11(55%)

6-9hrs

07(17%)

26(57%)

02(05%)

18 (53%)

0

03(15%)

9 -12hrs

01(02%)

06(13%)

0

02(06%)

0

01(05%)

The average total duration of labour in primigravida in study group was 4 hours and 45 minutes (285 min) and in control group was 6 hours and 50 minutes (410 min). The average total duration of labour in second gravid in study group was 3 and half hours (210 min) and in control group 5 hours (300). Total duration of labour was less in primigravida and second gravida in study group compared to control group as p < 0.05. There was no difference in study and control groups of third gravida as the results were statistically not significant.

Table 7: number of cervical tears

Group

Primigravida

Second gravida

Third gravida

Study

1

0

0

Control

3

2

0

One case of cervical tear was seen in study group, while there were 5 cases of cervical tears in the control group which were unilateral and requiring suturing.

Table 8: Apgar score of new born

SCORE

PRIMIGRAVIDA

SECONDGRAVIDA

THIRDGRAVIDA

STUDY

CONTROL

STUDY

CONTROL

STUDY

CONTROL

1”<7

04(9.5%)

06(13%)

02(06%)

07(20%)

04(17%)

02(10%)

1”>7

38(90.5%)

40(87%)

32(94%)

27(80%)

20(83%)

18(90%)

5”<7

02(05%)

02(04%)

0

01(03%)

0

01(05%)

5”>7

40(95%)

44(96%)

34(100%)

33(97%)

24(100%)

19(95%)

There was not much difference seen in the APGAR scores of babies in study and control group

Table-9: postpartum hemorrhage

Group

Primi

Gravida

Second

Gravida

Third

Gravida

Study

1

1

1

Control

3

4

1

Total three cases of PPH in the study group and eight in control group were observed. One in study group was due to cervical tear, 2 in study group were due to atony. 5 in control group were due to cervical tears, 3 due to uterine atony.

DISCUSSION:

AGE DISTRIBUTION

The range of age of the patients in present study is comparable to the range taken in various other studies. In present study maximum number of patients belongs to the age group of 21-25 years. This is comparable to several studies [7, 8] where maximum patients belonged to age group of 20-25.

COMPARISION ON PARITY

Most of the studies included only primigravida, present study includes second and third gravida also. In Present study 44% are primis, 34% are second and 22% are third gravida. Other studies [7, 8] included 100 primigravida. Another study [5] included 60 primis and 40 second gravida.

COMPARISON ON DURATION OF ACTIVE PHASE OF DILATATION IN LABOUR

In present study mean Duration of active phase labour was shorter in Drotaverine group than in control group. The average duration of dilatation stage was 250 minutes in primigravida of study group, while it was 390 minutes in control group. The average duration of dilatation stage was 180 minutes in second gravida of study group, while it was 270 minutes in control group. P value < 0.05 was statistically significant.

There was not much difference between study group and control group in third gravid as p>0.05. In a study [8], mean duration of active phase of labour was shorter in Drotaverine group (265.44 minutes) than placebo group (312.32 minutes). In a study [7] mean duration of active phase of labour was shorter in Drotaverine group (194 minutes) than Valethamate bromide group (220.7 minutes). In a study, [9] mean duration of active phase of labour was shorter in Drotaverine group (205 minutes) than Valethamate bromide group (275 minutes). The duration of active phase of labour was shorter in both the groups than in control group (373 minutes). In a study [2] mean duration of active phase of labour was shorter in Drotaverine group (183.6 minutes) than placebo group (236.6 minutes). The result of present study correlates with other studies.

DURATION OF SECOND STAGE AND THIRD STAGE OF LABOUR

In the present study there is no significant difference in the duration of second and third stage of labour with Drotaverine .this is supported by studies [5, 10] in the present study the duration of second stage was 29±5 min in primigravida in the study group as compared to the duration in controls which was 28±5min. In another study [5] the duration of second stage in the study group was 21.05±17min as compared to controls where it was 21.39±14min. In yet another Study [10] the duration of second stage in primigravida was 36.6±6 min compared to 36.5±5min in controls. In multigraavidas in the present study the duration of second stage was found to be 18±7min in the study group vs. 20±7min in controls as compared to the study [10] where it was 21.5±4.9min in the study group as compared to 21.46±1.8min in the control group. Regarding duration of third stage in the present study it was 5.2±1.91min in the study group vs. 5.1±1.82min in the control group. In another study [5] it was 4.62±1.46min in the study group vs. 4.92±1.50min in the control group. In yet another study [10] it was 4.40±1.7 min in the study group vs. 4.4±1.56 min in the control group. Thus all studies show similar findings.

COMPARISION OF THE TOTAL DURATION OF LABOUR FROM THE TIME OF ADMINISTRATION OF DROTAVARINE TO DELIVERY OF THE BABY

Total duration of labour was less in primigravida (285min vs. 210min) and in second gravid (210min vs. 300min) when study group was compared to control group and this was statistically significant (p<0.05). Thus Drotaverine is associated with shorter duration of labour. In another study [7] the duration between administrations of Drotaverine to delivery was 190min in study group vs. 410min in controls. Another study [8] showed duration of 288.52min in the study group vs. 348.3min in the control. In yet another study [11] this duration was also found to be shortened i.e.183.2min vs. 245min. Another study[5] showed a duration of 155.8min vs. 294min in primigravida and 108min vs. 194min in multigraavidas when the study group was compared to control group.

POST PARTUM HAEMORRHAGE:

In present study no significant difference between study and control group regarding atonic PPH was observed but PPH due to cervical tears was reduced in study group. However other studies [7, 8] showed that Drotaverine does not increase or decrease in incidence of PPH.

CONCLUSION:

Poor progress in labour because of rigidity of cervix is well recognized. It was observed that intramuscular administration of Drotaverine injection in the dilatation phase of uncomplicated pregnancies significantly reduces the duration of cervical dilatation, total duration of labour and incidences of cervical tears. Duration of labour is shortened significantly in primigravida. The drug is safe when used in pharmacological doses (40-80mg) and did not cause any adverse effects. It does not alter the second and third stage of labour. Drotaverine is a new aid in the management of a convenient, shorter, physiological and uncomplicated delivery.

REFERENCES:

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(2). Blasko G: Pharmacology, mechanism of action and clinical significance of a convenient antispasmodic agent: Drotaverine. JAMA Ind. The Physician update. 1998 July- Aug; 1(6): 63-69.

(3) Bolaji O: High performance liquid chromatography method for the determination of Drotaverine in human plasma and urine. J Chromatography Biomedical Application. 1993; 622: 93-97.

(4) Boloji O, Omeji CO, Ogundaini AO, Olug-bode E, et al: Pharmacokinetics and bioavailability of Drotaverine in humans. Europe J Drug Metab & Pharrnacokineties. 1996; 21: 217_221.

(5)Nagaria tripti et al: To compare and evaluate the efficacy and safety of Drotaverine and Valethamate bromide J Obstet Gynecol India Vol. 59, No. 4: July/August 2009 pg 324-33.

(6)Calkins LA: The length of labour. Am. J. Obstet & Gynecol. 1931;22: 604-610.

(7) Sharma JB, Pundir P, Kumar A, Murthy NS. Drotaverine hydrochloride vs. Valethamate bromide in acceleration of labour. International Journal of Gynecology & Obstetrics 2001 Sep;74(3):255-60.

(8)Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for augmentation of labour. Int J Gynecol Obstet India. 2004;84(1):17-22.

(9)Mishra SL et al. A comparative study of Hyoscine butyl bromide versus Drotaverine hydrochloride in first stage of labour J Obstet Gynecol India. 2002;52(3): 76-9

(10) Tehalia Manpreet K et al : A comparative study of Hyoscine butyl bromide versus Drotaverine hydrochloride in first stage of labour. J Obstet Gynecol India Vol. 58,No. 3 : May/June 2008

(11)Madhu C et al: A randomized controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour.2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31.





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